Cardiovascular disease is counted among the most common diseases in Western countries and its occurrence is further increasing. The most important individual risk factor is elevated serum LDL cholesterol level, and therefore, lowering of the cholesterol level is the most effective single measure regarding both prevention and effective treatment of cardiovascular disease.
The most important drugs for reduction of cholesterol levels are the statins, which primarily function by inhibiting the synthesis of cholesterol in the liver. The most common side effects of the statins are gastrointestinal, other less common side effects include headache, dizziness, rash, and sleep disturbances. In addition, statins may cause both liver damage and muscle disorders.
As an alternative, or in addition to medical treatment and the use of conventional drugs, attention has during the last decades been focused on reducing the risk for cardiovascular diseases by means of changing life style, in particular by increasing physical exercise, and adopting a low-fat or low-cholesterol diet. Another nutritional way to affect the cholesterol levels is to use cholesterol lowering agents in functional foods that can be a part of a conventional diet. This alternative has been greatly welcomed by consumers.
Food products enriched with components having cholesterol lowering effect have been commercially available for more than 15 years. Such food products usually contain plant sterols and/or plant stanols and especially their esters as active ingredient. Plant sterols have since the 1950's been known to effectively reduce serum cholesterol levels. U.S. Pat. No. 6,174,560 describes plant stanol fatty acid esters, a method for their preparation, and the cholesterol lowering effects thereof. An intake of 2 g per day of plant stanols is reported to lower serum LDL cholesterol levels in man up to 14%. Benecol® is a well-known trademark that nowadays is used in a large group of food products.
However, many consumers prefer to have their daily dose of plant sterol ester and/or plant stanol ester available in an easier form that can be carried along wherever they go, e.g. as a dietary supplement. This more corresponds to taking a drug like statin, and persons being used to take statins could easily at the same time have a plant sterol ester and/or plant stanol ester dose to further improve the lowering of their serum LDL cholesterol.
Dietary supplements based on plant sterol ester and/or plant stanol ester are currently marketed mainly as so-called soft gelatine capsules. However, one problem with this type of product is that the size of the soft gelatine capsule is big, causing problems with the swallowing of it. Such soft gelatine capsules typically deliver about 1 g plant sterol ester and/or plant stanol ester contained in each soft gelatine capsules. This means that the consumer has to swallow several big soft gelatine capsules per day to obtain the daily recommended amount of plant sterol ester and/or plant stanol ester. Many consumers have difficulties in swallowing such big capsules. Furthermore, the swallowing of such capsules involves simultaneous drinking of water or some other liquid and the capsules are therefore not so convenient to use.
Also chewable plant sterol ester and/or plant stanol ester dietary supplements have been described. However, the plant sterol ester and/or plant stanol ester concentration of the prior known chewable dietary supplement products is low, thus consumers need to take several servings of them to get the daily dose of plant sterol ester and/or plant stanol ester. Prior known dietary supplements also contain components, such as adsorbents, emulsifiers or other E-numbered additives, that are not desired by consumers in food products. Further, some of them contain a lot of sugar, which is not desired either. There is a need for a plant sterol ester and/or plant stanol ester composition that can be used as a chewable dietary supplement, and has a high plant sterol ester and/or plant stanol ester content, a low monosaccharide and disaccharide content, and good organoleptic properties, especially mouthfeel and texture. Further, dietary supplements with high triglyceride fat content would be advantageous, as the fat simultaneously ingested with plant sterol ester and/or plant stanol ester is thought to ensure effective cholesterol lowering. It would also be advantageous to have compositions with versatile usage. Also compositions that can be stored at room temperatures, and do not require refrigeration would be advantageous. Also a simple manufacturing method is beneficial. The current invention satisfies at least one, and preferably all of these needs.